Electrical stimulation to treat hair loss

ABSTRACT

A hair restoration apparatus includes an electrical generator configured to generate an electrical signal meeting defined characteristics. A controller in operative communication with the generator controls operation of the generator and characteristics of the generated electrical signal selected to effect a therapeutically effective application of electrical signals to a hair restoration site. An electrode in electrical communication with the electrical generator is disposed in an area where application of the electrical signal is desired. An electrical connection between the electrical generator and the electrode is provided and sealed for at least partial implantation under the skin of a patient in selected embodiments.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Application Ser. No. 60/353,706filed on Feb. 1, 2002; U.S. Application Ser. No. 60/353,694 filed onFeb. 1, 2002; and U.S. Application Ser. No. 60/358,176 filed on Feb. 20,2002.

BACKGROUND OF THE INVENTION

The present invention relates generally to the electrical arts. It findsparticular application in the medical arts where electrical or chemicalstimulation is provided for therapeutic purpose. It will be appreciatedhowever, that the present invention is also amenable to other fields ofendeavor where controlled, localized electrical stimulation is desired.

Hair loss is one of the biggest cosmetic concerns facing the societytoday. It is more common in men but also afflicts the female population.A large number of remedies and preventive measures have been tried forhair loss but still the hope for prevention of hair loss or promotion ofhair growth is a difficult and elusive goal. People subject themselvesto lengthy, expensive and painful surgeries or expensive use ofmedications with significant side effects including the growth of hairin unwanted areas.

Androgenetic alopecia, the medical term for male and female patternbaldness was only partially understood until the last few decades.Scientists previously thought it was caused by an overabundance oftestosterone. It is now known that dihydrotestosterone (DHT), aderivative of the hormone, is the detrimental agent that causes hairloss. Simply put, under certain conditions DHT “strangles” hairfollicles. While this process is the primary cause there are severalother factors that contribute to further deterioration of the hairfollicle such as: poor-circulation of the scalp, clogged or harshlytreated hair follicles, over active sebaceous glands, and nutrientdeficient hair follicles.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, an electricalapparatus for treating hair loss includes a power supply capable ofselectively generating an electrical signal and a controller inoperative connection with the power supply. An electrode mechanism isalso provided disposed adjacent to an area of hair loss. The electrodemechanism is in electrical communication with the power supply and isformable by a user to correspond to an area of hair loss.

In accordance with one aspect of the present invention, a hairrestoration apparatus includes an electrical generator configured togenerate an electrical signal having selected characteristics. Acontroller in operative connection with the generator controls theoperation of the electrical generator and characteristics of thegenerated electrical signal selected to effect a therapeuticallyeffective application of electrical signal to a hair restoration site.An electrode in electrical communication with the electrical generatoris disposed in an area where application of the electrical signal isdesired. An electrical connection between the electrical generator andthe electrode is sealed for at least partial implantation under the skinof a patient.

DESCRIPTION OF THE DRAWINGS

The invention may take form in various components and arrangements ofcomponents and in various steps and arrangements of steps. The drawingsare only for purposes of illustrating the preferred embodiments and arenot to be construed as limiting the invention. Moreover, the drawingsare not to scale and certain elements may be illustrated in exaggeratedform for clarity or to illustrate particular features.

FIG. 1 illustrates a system suitable to practice the present invention;

FIG. 2 is a cross sectional view of the electrode taken along linesII-II in FIG. 1;

FIG. 3 is a perspective view of an alternative embodiment suitable topractice the present invention;

FIG. 4 is a side view of a subcutaneous implant;

FIG. 5 is a side view of a subgaleal implant;

FIG. 6 illustrates a dome infusion reservoir;

FIG. 7 illustrates an alternate dome infusion reservoir;

FIG. 8 illustrates a catheter tip with capability for perineuralinsertion;

FIG. 9 is a cross-sectional view of a stimulator device suitable topractice an aspect of the present invention;

FIG. 10 is a view of a stimulator device; and

FIG. 11 is a view of a burr hole ring with three groves.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to FIG. 1, a hair restoration apparatus 10 includes apower supply 12, a controller 14, and an electrode 16. The controller 14is operatively connected to the power supply and controls the electricalsignal output from the power supply 12. Particularly, the electricalsignal generated preferably includes a voltage between 0.1 μV and 20 V,a pulse within the range of 10 microseconds to 1000 microseconds, afrequency in the range of 2 Hz to 2500 Hz, and combinations thereof.While the controller 14 is illustrated as a separate component from thepower supply 12, those skilled in the art will appreciate that alternateembodiments are possible without departing from the scope of the presentinvention. These include a controller packaged with a power supply orbeing an integral part of the power supply and the like. It is furtherappreciated that when it is desirable to implant the power supply andthe controller, a combination of the two components into a singlepackage is often desirable. In the illustrated embodiment of an externalcontroller 14, the electrical signal characteristics are selected viamanual switches 18. In alternate embodiments, the electrical signalcharacteristics are controlled via a microprocessor controlled componentof the controller contained, for example, on an application specificintegrated circuit (ASIC). In yet further embodiments, an implantedcontroller is controlled via telemetry, magnetic, radio frequency, andthe like control mechanisms. Systems for communicating with implantablemedical devices are disclosed for example in U.S. Patent Application No.20020082665 entitled System And Method Of Communicating Between AnImplantable Medical Device And A Remote Computer System Or Health CareProvider and U.S. Patent Application No. 20010012955 entitled Method AndApparatus For Communicating With An Implantable Medical Device, and U.S.Pat. No. 6,201,993 entitled Medical Device Telemetry Receiver HavingImproved Noise Discrimination, and are incorporated by reference herefor their teachings.

In the illustrated embodiment, power supply 12 is electrically connectedwith the electrode 16 by an insulated coupling or electrical lead 20. Inthe case of an externally located power supply and implanted electrode,coupling 20 passes through the skin 22 of a patient to establishelectrical conductivity with the implanted electrode 16. In anembodiment, the electrode 16 is formable by cutting, tearing, orseparating perforations to substantially conform with the area wheretreatment is desired. It is to be appreciated that various sizes ofelectrodes are provided to minimize waste in matching an appropriatelysized electrode with the area to be treated such as a hair restorationsite.

As best seen by reference to FIG. 2, the electrode is generally flat andincludes an identifiable first side 30 placed or implanted such that itlies close or adjacent to the treatment area. In one embodiment,electrode 16 further includes a second side 32 comprising anelectrically insulating material to minimize electric field away fromthe area of interest. In this embodiment, the electric field issubstantially directed away from the electrode toward the treatment area(indicated by arrows in FIG. 2) while the electrical field is minimizedon the opposite side.

In certain embodiments, particularly non-implanted embodiments, theelectrode is externally applied in a pad form, as part of a cap or hairnet, or in a grid configuration.

With reference now to FIG. 3, an electrode 16′ is configured withelectrically conductive needles or extensions 40 that are gently pressedinto the treatment area. In this embodiment, the electrical fieldgenerated radiates generally in circular or hemispherical patternsaround the needles.

In implantable embodiments, the electrode inserted beneath the treatmentarea as further explained below. In still other embodiments, theelectrode is surgically placed in an area of the hypothalmus using, forexample, deep brain surgical techniques as know by neuro surgeons andskilled artisans. Preferably such an implant is programmed to disruptthe production of testosterone or derivatives thereof.

With reference now to FIG. 4, the electrode 16 is placed subcutaneously.It is now apparent that such a placement can be achieved through a smallincision and subsequent insertion of a folded electrode. The procedureis completed by unfolding or forming the electrode beneath the skin withonly the electrical lead 20 protruding. As discussed above, alternateembodiments include an entirely implanted system where the insulatedcoupling extends from the electrode subcutaneously to an implanted powersupply.

With reference now to FIG. 5, an electrode array 16″ is effective as asubgaleal implant. Such an implant is most preferably achieved byinserting a folded electrode array and subsequently forming or spreadingthe array in place.

With reference now to FIG. 6, another embodiment of the presentinvention provides a microinfusion system 50 including a domed-typechamber or reservoir 52 which in the illustrated embodiment can containa single medication. Multiple dose chambers are also within the skill ofan artisan. The system further includes a base 54 having a radius largerthan the base of the reservoir 52. Incorporated into the base 54 areoutlets 56 at opposing sides of the reservoir 52. Those skilled in theart can appreciate that in alternative embodiment, many outlets may bespaced about the periphery of the base 54. The system also includes adose control 60 which regulates the rate of medication to outlets 56.

In one embodiment of the invention illustrated in FIG. 6, the exteriorshell 62 of the reservoir 56 includes a penitratable surface such that ahypodermic needle, for example, may be used to replenish a medicationsupply without removing the entire system.

In an alternate embodiment, the system illustrated in FIG. 6 is a singleuse, preloaded system which remains in place until the supply ofmedication is exhausted. Those of ordinary skill in the art canrecognize that the size of such a system permits subcutaneousimplantation, both for cosmetic reasons and to place the medicationcloser to the area where needed.

With reference now to FIG. 7, an alternate embodiment of the systemincludes an extended catheter tip 70 for depositing medication to a deepor remote location such as in deep brain infusion. Also illustrated is asensing embodiment. A fiber optic or other sensor 72 is included forsensing the medication at the point of interest. A feedback loop 74permits the dose controller 60 to adjust the rate of medication deliverydepending on the sensed data. As is now evident from continued referenceto FIG. 2, medication can alternately flow from both the extendedcatheter 70 as well as outlets 56.

Referring now to FIG. 8, the system is shown with a catheter 80connected to outlets 56. As is apparent from FIG. 8, the catheter may beinserted into an area of interest, such as a peripheral nerve 82 asillustrated.

In one embodiment, the device consists of a domed type chamber which mayhave septations to allow the introduction of one, two, or multiple drugsinto an area of interest including the central or peripheral nervoussystem with a microcatheter, or an area directly on the scalp. Thedevice in one embodiment can also have a fixed or electronicallyadjustable valve system to allow a particular dosing of the drug. Inanother embodiment, there are sensors at the output end of the chamberproviding feedback to automatically adjust the dosing. Additionally,this system can be attached to currently existing deep brain stimulationburr hole devices.

In an alternate embodiment, the device comprises the actual burr holering. For example, the circle of the ring will include a chamber orreservoir with a port for injection and a tab or notch for insertion ofa cannula and a notch for insertion of an electrode.

The system in its one form would be a disposable system for fixed dosinga single medication which could be implanted in a patient as a tool fortrial chemical modulation. Prior to the present invention, this wasaccomplished through the implantation of a large and bulky drug deliverysystem having a diameter of about 7.5 cm.

In other forms the system is semi-permanent and reusable but still morecompact than present drug delivery systems.

The system is smaller than that which is presently available which isadvantageous when delivering drug/chemical within the substrate of theentral or peripheral nervous system. Also, dosing concentrations fordirect nervous system injection are in order of magnitude smaller thaneither oral, intravenous, or intrathecal dosages.

In yet other forms, the system allows the delivery of multiple types ofdrugs, chemicals, medication and the like. The system allows controlledmedication delivery such that a microinfusion device adds drugs,neurotransmitters, Rogaine, or other such material to the localenvironment at a determined rate. Moreover, other embodiments includecombinations of electrical and chemical neuromodulation. The chemicalagent may be a neurotransmitter mimic; neuropeptide; hormone;pro-hormone; antagonist, agonist, reuptake inhibitor, or degradingenzyme thereof; peptide; protein; therapeutic agent; nucleic acid; orstem cell and may be delivered by a slow release matrix or drug pump.Although such chemical agents are generally administered orally intraditional pharmacotherapies, by directly stimulating the target sitesthat synthesize or release such products, low and precise doses of thechemical agents can be administered so as to minimize or avoid the sideeffects and delayed onset of relief common to traditionalpharmacotherapy.

The system is subcutaneously implantable.

The system can be utilized for delivery of drugs/chemicals/gene therapyvectors/viral vectors into the central or peripheral nervous system.

Dosed delivery of chemotherapy or antibiotic over the course of manydays to weeks.

The applications of the invention includes drug delivery forParkinson's-Disease Essential tremor, MS, Dystonia, cerebral palsy,psychiatric disorders, obsessive compulsive disorder, depression,Mucimol, Dystonia, ALS, Gene therapy vectors to allow delivery ofsubstance retrograde through the peripheral nerves. Controlledantibiotic therapy for meningitis bacterial or chemical. Chemotherapyfor carcinomatous meningitis, or central nervous system lymphoma orother metastatic disease.

Another embodiment of the present invention includes set of compact RFcompatible receiving coils or a smaller temporary impulse generatorwhich is coupled to an already implanted deep brain stimulatorelectrodes, other neurostimulation electrodes such as those used formotor cortex or spinal cord stimulation, or generally to implantedelectrodes anywhere. This compact receiving RF coil or smaller temporaryimpulse generator can be implanted in the subgaleal space and can beexternally stimulated with an accessory external antenna (outside of theskin) connected to a battery powered transmitter (in the case of an RFsystem). Such coil systems permit externally applied signals to becommunicated to electrodes without dedicated pulse generators in eachinstance or otherwise when dedicated generators are undesirable.

With reference now to FIG. 9, a neurostimulator according to oneembodiment of the present invention includes a cap 90 which rests snuglyin a burr hole ring 92 overlaying a region of interest. Disposed withincap 90 are antenna windings 100 which are suitable for receiving RFradiation from a transmitter 102. A lead 106 from winding 100 connectswith windings 108 associated with burr ring 92. In the illustratedembodiment, burr ring 92 includes a plurality of channels C in which thewindings reside. At an end of channel C towards central opening 110 theimplanted electrode is electrically connected to the winding 108. Asthose skilled in the art can appreciate, this completes the electricalconnection between the coil or winding 100 and the electrode tipdisposed in the treatment site (not shown). It can now be appreciatedthat other electrode locations are possible without departing from thescope of the invention.

With reference now to FIG. 10, a plan view of the cap 90 is illustratedpartially cut away to reveal windings 100 disposed therein. As thoseskilled in the art can appreciate, the cap is preferably made from amaterial which will readily pass the received RF energy to the coil orwindings 100 disposed within.

With reference now to FIG. 11, a plan view of the burr ring 92 reveals achannel C through which the winding 108 is wrapped. The ring has a gap Gpermitting, among others, custom and secure fit within the burr hole.

Desirably, its smaller size would allow for its implantation into thehead or via a small incision after the insertion of a percutaneousspinal cord stimulator system. Additionally, It would be cheaper andsmaller than the currently available totally implantable pulsegenerators.

With respect to particular details of electrical stimulation accordingto aspects of the present invention, once the electrode is secured atthe target site, the stimulation controller is activated therebyapplying to the target site an oscillating electrical signal havingspecified pulsing parameters. The oscillating electrical signal may beapplied continuously or intermittently and the pulsing parameters, suchas the pulse width, amplitude, frequency, voltage, current, intensity,and/or waveform may be adjusted to affect a desired result. Preferably,the oscillating electrical signal is operated at a voltage between about0.1 μV to about 20 V. More preferably, the oscillating electrical signalis operated at a voltage between about 1 V to about 15 V. Preferably,the electric signal is operated at a frequency range between about 2 Hzto about 2500 Hz. More preferably, the electric signal is operated at afrequency range between about 2 Hz to about 200 Hz. Preferably, thepulse width of the oscillating electrical signal is between about 10microseconds to about 1,000 microseconds. More preferably, the pulsewidth of the oscillating electrical signal is between about 50microseconds to about 500 microseconds. Preferably, the application ofthe oscillating electrical signal is: monopolar when the electrode ismonopolar, bipolar when the electrode is bipolar, and multipolar whenthe electrode is multipolar. In addition, we can generate variouswaveforms such as sine wave and others in addition to the square waveforms of stimulation.

Notwithstanding whether chemical and/or electrical stimulation isemployed in embodiments of the present invention, also contemplated areuse of a closed-loop feedback mechanism in conjunction with chemicalstimulation, electrical stimulation, or both. Such physiologicalactivity to be detected is a physiological characteristic or function ofthe body, and includes, for example, testosterone, estrogen or one oftheir metabolites level being detected in the body, blood, subcutaneoustissue, and the like.

The description above is intended to provide illustrations of some ofthe presently preferred embodiments of the invention. In light of theabove description and examples, various other modifications andvariations will now become apparent to those skilled in the art withoutdeparting from the spirit and scope of the present invention as definedby the appended claims. For example, disorders treatable by the presentinvention include hyperandrogenic Alopecia—occuring for example inpremenopausal females, Alopecia Aerata, Androgenetic Alopecia, Drugindued Alopecia, Alopecial Aerata, and the like. Accordingly, the scopeof the invention should be determined solely by the appended claims andthe equivalents thereof.

1. A method of treating hair loss in a patient suffering from hair loss,comprising: providing an electrode having a conductive side and aninsulated side; surgically implanting the electrode under the skin ofthe patient adjacent the hair loss are such that the implantedconductive side faces the hair loss area and the implanted insulatedside faces away from the hair loss area, wherein an electric fieldgenerated by the electrode is directed substantially towards the hairloss area; generating an electrical signal; adapting the electricalsignal to comprise a voltage in the range of 0.1 microvolts to 20 volts;coupling the adapted electrical signal to the electrode; and applyingthe adapted electrical signal through the electrode to the hair lossarea and treating said hair loss.
 2. The method as set forth in claim 1,further comprising: adapting the electrical signal to comprise afrequency in the range of 2 hertz to 2500 hertz.
 3. The method as setforth in claim 1, further comprising: adapting the electrical signal tocomprise a pulse width in the range of 10 microseconds and 1000microseconds.
 4. The method as set forth in claim 1, further comprisingextending a lead from the electrode for connection to an electricalsignal generator.
 5. The method of claim 1, further comprising;conforming the shape of the electrode to the hair loss area.